Renal transplantation
Conditions
Interventions
Trade Name: Myfortic 360mg film-coated gastro-resistant tablets
Product Name: Myfortic 360mg film-coated gastro-resistant tablets
Product Code: ERL080
P
Sponsors
Novartis Pharmaceuticals UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients that have received a kidney transplant; 2. Receiving immunosuppressive regimen that includes MMF; 3. Patients suffering GI side effects related to standard MMF doses or patients on reduced dose MMF with existing but tolerated/controlled GI side effects. 4. At least 18 years of age; 5. Willing to provide written informed consent; 6. Able to meet all study requirements and completing three study visits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral bisphosphonate induced, infectious diarrhea); 2. Acute rejection < 1 week prior to study enrollment; 3. Women of child-bearing potential who are planning to become pregnant or are pregnant and/or lactating who is unwilling to use effective means of contraception; 4. Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements; 5. Undergoing acute medical intervention or hospitalization; 6. Any other medical condition that, in the opinion of the site investigator based on recall or chart review would interfere with completing the study, including but not limited to, visual problems or cognitive impairment. 7. Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess whether treatment with an enteric coated formulation of mycophenolic acid (MPA) permits higher MPA doses to be maintained, than treatment with standard MMF therapy, in patients with demonstrated susceptibility to gastro intestinal side effects;Secondary Objective: The secondary objectives are to determine the effect of the use of the enteric coated formulation of MPA on patient reported outcomes, in patients who warrant conversion from MMF or require a reduced dose of MMF because of GI side effects. Symptom severity is assessed by the Gastrointestinal Symptom Rating Scale (GSRS) and Bristol stool form chart; HRQL is assessed by the Gastrointestinal Quality of Life Index (GIQLI) and SF-36.; Primary end point(s): The primary efficacy assessment will be based on the proportion of patients who are maintained at Visit 4 on a dose that is at least one dosage step greater than at baseline (Visit 2). Table 6.1 shows the dosage steps corresponding to 25%, 50% and 100% of the target therapeutic dose for each drug. The main secondary efficacy assessment of GI complaints will be based on changes from baseline to Visits 3 and 4 in the diarrhoea and indigestion subscales of the GSRS instrument and compared between the Myfortic and standard therapy groups. For GSRS, a higher score represents greater impairment of quality of life due to GI symptoms. The comparisons between the groups will be based on confidence interval as well as hypothesis testing approaches. An analysis of covariance (ANCOVA) model will be fitted including terms for treatment, dose level (expressed as a proportion of the target therapeutic dose), baseline GSRS, and centre. The possibility of a treatment by centre interaction, or a treatment by baseline GSRS interaction will be examined, although the interaction terms will not be included in the primary analysis model. The least squares mean (“adjusted mean”) change | — |
Countries
Ireland, United Kingdom
Outcome results
None listed